ABPI clinical-trial disclosure toolkit

Keeping
with its promises, Association of the British Pharmaceutical Industry
has launched a clinical-trial disclosure toolkit to help its member
businesses observe with transparency needs for information from or
about clinical trials.

This
was initiated in February, when the ABPI unveiled a new set of
measures to help improve compliance with data-transparency clauses in
its Code of Practice.

As
per the code, all member businesses must register a clinical trial
within 21 days of the first patient being admitted to the trial and
post the results within a year of the novel drug being granted a
marketing authorization.

The
disclosure toolkit would be updated regularly to depict changes in
international regulatory requirements like the new data transparency
policy scheduled for a launch by the European Medicines Agency ,
comprises 11 documents including disclosure checklists, good practice
guidelines and a template standard-operating procedure (SOP).

What
are the minimum requirements?

It
is not intended as regulatory or legal solution. A Points
to Consider document provided as part of the toolkit notes that
country laws, the International
Federation of Pharmaceutical Manufacturers and Associations’ Joint
Position paper and
the ABPI
Code of Practice give the
framework and define minimum requirements for disclosure of
clinical-trial information. But it adds a sponsor company might
decide to go beyond the minimum requirements. Some businesses have
chosen to release information about all clinical researches,
regardless of phase, design or participant type, while others at
least disclose information about all patient trials either
interventional and non-interventional and regardless of the phase of
the trial.

To
mentions, any such decision is endorsed by senior management who
would own the company disclosure policy,as stated by the the
document.

Patient-level
data

The
considerable points also address critical issues for example
third-party access to patient-level data, which calls for a robust
process to remove any information that could contribute to the
re-personalization of clinical-trial data.

If
a business decide to share patient-level data, the document points
out, it should clarify and define in a Disclosure SOP concerns such
as :

Explanation
of patient-level data

Whether
requests from any entity either commercial or not will be
considered.

What
criteria the requesting party needs to content in terms of evidence
of capability and availability of good analysis practice.

What
the requester requires to submit with respect to an analysis,
quality-control and publication plans.

Controls
to assure adequate anonymity of patient level data and removal of
other sensitive data.

Timeliness
for providing response and satisfying data requests.

Strong
advocate

The
ABPI is a strong supporter for transparency in clinical research
information, as stated by Stephen Whitehead, the association’s
chief executive.

He
added that earlier this year they committed to provide a clinical
trial disclosure toolkit to businesses and he’s delighted that this
is now available on their website for any company usage. Whitehead
added that as part of a global industry and with the UK contributing
fewer than 2% of all patients recruited to clinical researches
worldwide, they are actively engaging with their European and
international counterparts to input into ongoing discussions around
clinical research transparency.

Clinical
data transparency is an important issue for all.

It
important to ensure that any research practices are transparent,
responsible, and fully compliant with applicable laws, regulations
and guidelines.

It
needs dedicated and trained staff for purposes of timely
registration of clinical trials, communication of trial results, and
publication of all sponsored trials and research studies.

A
proper collaboration with external medical researchers to advance
clinical research and enhance public health.